Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K896331
Device Name V2465P X-RAY IMAGE INTENSIFIER
Applicant
Hamamatsu Photonics K.K.
360 Foothill Rd.
Box 6910
Bridgewater,  NJ  08807
Applicant Contact RALPH ENO
Correspondent
Hamamatsu Photonics K.K.
360 Foothill Rd.
Box 6910
Bridgewater,  NJ  08807
Correspondent Contact RALPH ENO
Regulation Number892.1650
Classification Product Code
JAA  
Date Received11/02/1989
Decision Date 12/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-